Bush Administration’s preemption claims blasted in report

Federal preemption is finally showing up on the radar screen of Democrat lawmakers in our Nation’s Capitol. A recent report issued by the House Oversight and Government Reform Committee is proof positive that the Bush Administration has pulled out all stops to shield drug companies from liability for dangerous drugs while leaving patients out in the cold. The report, based on documents obtained from the Food and Drug Administration, concludes that the agency’s efforts to protect drug companies delayed the dissemination of important safety information to the public. The documents reveal that top FDA officials who deal with drug safety on a day-to-day basis don’t believe that lawsuits undermine consumer safety. But their views were overridden by President Bush’s political appointees, who lacked any empirical support for their views.

The Bush Administration has been very unfriendly to consumers over the last eight years and will go down as having had the worst consumer record in history. It’s bad enough that politics consistently trumps science with this Administration, but there is now clear documentation of how the White House hijacked the FDA and forced the agency to undermine its own mission, which is to protect American citizens.

The Bush Administration argued before the U.S. Supreme Court last month when the Justices heard the appeal in the Wyeth v. Levine case that civil suits arising from defective and mislabeled prescription drugs are preempted by approval by the FDA of the drug’s label. The report clearly shows that the Bush Administration’s pro-preemption position in the Wyeth case is motivated by politics and not expertise in drug regulation. Top-ranking FDA career officials with deep expertise in drug safety said that the Bush Administration’s efforts to amend drug labeling regulations to preempt state liability lawsuits were deeply flawed. The Administration’s justifications for the regulations were “false and misleading,” according to these officials.

As we have reported in previous issues, the Bush Administration has not limited its preemption push to prescription drugs. The preemption clauses are being inserted in a wide array of regulations. The White House takes the position that victims are not entitled to anything – no matter how negligent or irresponsible a company was in designing, testing, labeling or marketing its products – and that’s morally and legally wrong. This effort to prevent injured citizens from having access to the courts and holding negligent companies accountable must be defeated. If the courts don’t follow the law and do the right thing, it will be up to Congress to protect the American people.